Phaseolamin compositions and methods for using the same

ABSTRACT

The present invention is for compositions containing phaseolamin and a mineral, such as chromium or vanadium or both, where the mineral is bound by a glycoprotein matrix. The present invention is also directed to methods for controlling carbohydrate cravings, inducing weight loss, reducing insulin requirements in a diabetic, and inhibiting the absorption of dietary starch by administering a composition of the invention.

The present application is a divisional of, and claims priority to, U.S.application Ser. No. 10/233,643 filed Sep. 3, 2002, now U.S. Pat. No.6,900,174 which is a divisional application of U.S. application Ser. No.09/962,917, filed Sep. 25, 2001, which has issued as U.S. Pat. No.6,797,287.

BACKGROUND OF THE INVENTION

Glycoproteins (glycosylated proteins) are organic compounds composed ofboth a protein and a carbohydrate joined together by a covalent linkage.Glycosylated proteins are present on extracellular matrices and cellularsurfaces of many cells. Oligosaccharides consist of a few covalentlylinked monosaccharide units, such as glucose and ribulose. Theoligosaccharide moieties of glycoproteins are implicated in a wide rangeof cell-cell and cell-matrix recognition events.

The addition of carbohydrates such as oligosaccharides, on a proteininvolves a complex series of reactions that are catalyzed bymembrane-bound glycosyltransferases and glycosidases.Glycosyltransferases are enzymes that transfer sugar groups to anacceptor, such as another sugar or a protein. Glycosidases are enzymesthat remove sugar groups. The types and amounts of sugars that areattached to a given protein depend on the cell type in which theglycoprotein is expressed. In addition, the types of linkage used tojoin various sugar groups together also confound the complexity ofglycosylation.

The biological activities of many glycoproteins are not detectablydifferent if the carbohydrates are removed. However, glycosylation ofproteins may have several effects. Carbohydrates often lengthen thebiological life of a protein by decreasing the protein's rate ofclearance from the blood. In addition, carbohydrates may help a proteinto fold properly, stabilize a protein, or affect physical propertiessuch as solubility or viscosity of a protein.

Phaseolamin is a glycoprotein found mainly in white and red kidney beansand is known to be an amylase inhibitor. Amylase is an enzymeresponsible for the breakdown or digestion of starch. Starch is the mainsource of carbohydrates in the human diet. The digestion of starchbegins in the mouth. Alpha-amylase present in saliva randomly hydrolyzesthe α(1→4) glucosidic bonds of starch except for the outermost bonds andthose next to branches.

By the time the thoroughly chewed food reaches the stomach, the averagechain length of starch is reduced from several thousand to less thaneight glucose units. The acid level in the stomach inactivates thealpha-amylase. Further digestion of starch continues in the smallintestine by pancreatic alpha-amylase, which is similar to that ofsalivary alpha-amylase.

Decreasing the absorption of carbohydrates by inhibiting the digestionof starch is a very promising strategy in the fields of, for exampleweight loss and diabetes mellitus. From a dietary standpoint, it isimportant to target the breakdown of starch since starch is a relativelynonessential nutrient, which provides calories with fairly littlebenefit. Furthermore, as starch is broken down into simple sugars andabsorbed from the digestive tract, the pancreas is triggered to produceinsulin. Increase in insulin production causes an individual to feelhunger.

Several clinical studies, however, demonstrated that commerciallyavailable crude bean amylase inhibitors, when given with a starch meal,failed to influence fecal calorie excretion, postprandial concentrationsof plasma glucose or breath hydrogen, and metabolism of ¹³C-labeledstarch. In addition, administration of amylase inhibitors has beenassociated with side effects, such as abdominal discomfort and diarrhea.

It is estimated that approximately 40% of the United States populationsuffer from obesity (Glazer, G. (2001) Arch. Intern. Med. 161:1814–1824). Obesity has been associated with many illnesses, such ascardiovascular disease, respiratory illness including asthma, sleepapnea, pick-wichian syndrome, diabetes mellitus and pulmonaryhypertension. In addition, adenocarcinoma of the esophagus and gastriccardia (Lagergren, J. et al. (1999) Ann. Intern. Med. 130: 883–890),hepatic necrosis, and cirrhosis (Ratziu, V. et al. (2000)Gastroenterology 118: 1117–1123) have recently shown strong correlationwith obesity.

Approximately 90% of all obese individuals who try to lose weight fail.One reason is that the majority of obese individuals are reluctant togive up eating certain foods, including starches (i.e., pasta, bread,and potatoes). Therefore, a dietary supplement that effectively inhibitsthe digestion and breakdown of starch, without harmful side effects,will be beneficial in helping these individuals achieve weight loss.

In addition to assisting weight loss, inhibiting the digestion orbreakdown of starch may also be beneficial in illnesses such as, forexample, diabetes mellitus. Currently, between 120 and 140 millionpeople worldwide suffer from diabetes mellitus and by the year 2025, itis estimated that this number may double. Much of the increase inindividuals suffering from diabetes mellitus will occur in developingcountries due to population aging, unhealthy diets, obesity, and asedentary lifestyle.

Diabetes mellitus is a chronic disease characterized by a deficiency inthe production of insulin by the pancreas, or by ineffectiveness of theinsulin produced to utilize glucose. This impairment in glucoseutilization results in increased concentrations of glucose in the blood,which leads to damage of many of the body's systems, such as the bloodvessels and nerves. Therefore, preventing the breakdown of starch intosmaller sugar units, such as glucose, will be beneficial in theprevention and/or treatment of diabetes mellitus.

Numerous articles have been published concerning amylase inhibition.Some of these articles have indicated that amylase-inhibitors workedwell in vitro, but failed to be effective in humans. Some of theproffered reasons were 1) insufficient activity; 2) destruction in thegastrointestinal tract; 3) suboptimal pH conditions; and 4) differinggastric emptying rates of starch and inhibitor.

Previous attempts to block starch absorption have failed for manyreasons including the instability of the starch-blockers employed. Thus,there remains a need for a stable, inhibitor of starch digestion withenhanced bioactivity and decreased side effects.

SUMMARY OF THE INVENTION

The present invention is for a composition comprising phaseolamin and amineral, where the mineral is bound by a glycoprotein matrix. In oneembodiment, the mineral is chromium or vanadium or both. In anotherembodiment, the composition also comprises microorganisms. In yetanother embodiment, the microorganisms produce the glycoprotein matrix.

In a preferred embodiment, the microorganisms include yeast, such asSaccharomyces cervisiae. In another embodiment, the microorganismsinclude bacteria such as Lactobacillus, including Lactobacillusacidophillus or Bacterium bifidus. In yet another embodiment, themicroorganisms include both yeast and bacteria.

In one aspect of the invention, the composition also comprisesstabilizers and/or additives. In another aspect, the composition isadded to a baking mix such as pancake, waffle, bread, biscuit and cookiemix.

The present invention is also directed to a method for inhibitingabsorption of dietary starch in a host. The method comprisesadministering to a host, an effective amount of a composition comprisingphaseolamin and a mineral, such as, for example, chromium or vanadium orboth. The mineral is bound by a glycoprotein matrix.

In one aspect of the invention a method for inducing weight loss in ahost in need thereof is provided. The method comprises administering aneffective amount of a composition comprising phaseolamin and a mineral,such as, for example, chromium or vanadium. The mineral is bound by aglycoprotein matrix.

In another aspect of the invention, a method for controllingcarbohydrate cravings in a host in need thereof is provided. The methodcomprising administering an effective amount of a composition comprisingphaseolamin and a mineral, such as, for example, chromium or vanadium orboth. The mineral is bound by a glycoprotein matrix.

In a final embodiment, a method for decreasing insulin requirements in adiabetic host is provided. The method comprises administering to thehost, an effective amount of a composition comprising phaseolamin and amineral, such as, for example, chromium or vanadium or both. The mineralis bound by a glycoprotein matrix.

BRIEF DESCRIPTION OF THE FIGURE

FIG. 1.: Efficacy of Phaseolamin

The efficacy of phaseolamin was compared in two groups, one receiving astarch-meal(placebo), the other receiving a starch meal plusphaseolamin. The plasma glucose levels of the two groups were compared.The group receiving the phaseolamin had markedly lower plasma glucoselevels during the time after the starch meal was consumed.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, a composition is providedwhich includes phaseolamin and a mineral, wherein the mineral is boundto a glycoprotein matrix. The composition of the invention providesimproved stability and bioactivity characteristics of the mineral, inconjunction with the starch inhibition properties of phaseolamin.

The glycoprotein matrix of the present invention is bound to at leastone mineral. The glycoprotein matrix and mineral can be associated witheach other physically and/or chemically, such as by chemical reaction,and/or secondary chemical bonding, e.g., Van der Waals forces, etc. Notbeing bound by theory, it is believed that the glycoprotein matrix maybe bound to the mineral by weak covalent bonds.

The composition can contain essentially any percentage of mineral andphaseolamin as desired. For example, the percentage of mineral can varybetween 0.1 and 99% by weight of the composition depending upon themineral and the desired result in the host. The percentage ofphaseolamin can vary between 0.1 and 99% by weight of the compositiondepending upon desired result in the host.

Glycoprotein Matrix

The glycoprotein matrix is the glycoprotein to which the mineral isbound. Glycoprotein is a composite material made of a carbohydrate groupand a simple protein. A glycoprotein matrix is a molecular networkcomprised of a plurality of glycoprotein molecules bound together.

The carbohydrate in the glycoprotein can be any suitable carbohydrate,such as a monosaccharide, disaccharide, oligosaccharide, orpolysaccharide. Oligosaccharide is preferred. The protein of theglycoprotein can be any suitable polypeptide. The ratio of carbohydrateto protein in the glycoprotein matrix can vary, for example, from 99:1to 1:99 by weight. A ratio of approximately 1:1 is preferred.

The ratio of glycoprotein matrix to mineral can also vary. It ispreferred that the ratio of glycoprotein matrix to mineral will be suchthat all or nearly all of the mineral in the composition is bound byglycoprotein matrix. To ensure that essentially all of the mineral isbound, higher ratios of glycoprotein matrix to mineral can be used.

The invention also contemplates a composition where there may beinsufficient glycoprotein to bind the entire amount of the mineral. Insuch cases, the ratio of glycoprotein matrix to mineral can be less.

In a preferred embodiment, the source of the glycoprotein matrix is amicroorganism and, therefore, a preferred composition of the inventionwill include microorganisms. At the end of the manufacturing process ofthe composition, these microorganisms are usually inactive.

The glycoprotein matrix can be bound to the mineral by allowing themicroorganism to ferment, in the presence of the mineral. As usedherein, fermentation is the process by which microorganisms metabolizeraw materials, such as amino acids and carbohydrate, to produceglycoprotein.

The microorganisms produce glycoprotein both intracellularly andextracellularly The intracellular glycoprotein will mainly be located inthe cytoplasm of the microorganism or become part of the microorganism'sphysical structure. The glycoprotein from the microorganism that formsthe glycoprotein matrix is mainly extracellular and, therefore, isavailable to be bound to the mineral. Intracellular glycoprotein canalso be made accessible for binding to the mineral by rupture of themicroorganisms after glycoprotein production.

Microorganisms that produce a glycoprotein matrix include, but are notlimited to, yeast and some bacteria. A preferred yeast is Saccharomycescervisiae. Bacteria that produce glycoprotein include bacteria withinthe genus Lactobacillus. For example, such bacteria include, but are notlimited to, Lactobacillus acidophillus, Lactobacillus bulgaricus,Lactobacillus caucasicus, and Bacterium bifidus. Preferred bacteriainclude Lactobacillus acidophillus, and Bacterium bifidus.

Combinations of microorganisms can be used provided that at least one ofthe microorganisms produces glycoprotein. When using combinations ofmicroorganisms, the growth of one type of microorganism should notprevent the growth of the other. For example, various types of differentyeast that produce glycoprotein can be used. Also, yeast and bacteriacan be combined to produce glycoprotein. This combination isparticularly advantageous because various types of bacteria, such asLactobacillus acidophillus, also produce glycoprotein.

Stabilizers and Additives

The composition of the invention can also include stabilizers and/oradditives. Stabilizers and additives can include, for example,pharmaceutically acceptable buffers, excipients, diluents, surfactants,adjuvants, flavorings, and the like. The amounts of such additives canbe determined by one skilled in the art.

Additives can also include, for example, natural sources of the activeingredient to be administered. Other additives can be added which, forexample, improve the viability of the microorganisms that produce theglycoprotein or increase the yield of glycoprotein that becomes bound tothe active ingredient. For example, salts can be added in order toincrease the viability of the microorganism. Such salts include, but arenot limited to, calcium carbonate, ammonium sulfate, and magnesiumsulfate. Calcium carbonate is preferred. The amount of salt added to themicroorganism solution should be sufficient to obtain the desired resultof improving the viability of the organism, as is known in the art. Apreferred range of salt added to the microorganism solution is betweenabout 25 to about 150 grams of salt per 375 grams of microorganism, suchas Saccharomyces cervisiae. Approximately 40 g of salt per 375 gram ofmicroorganism is most preferred.

The composition of the invention can be manufactured so as to bebiocompatible. Since the mineral is to be ingested, the microorganismused to produce the glycoprotein matrix should be suitable forconsumption by mammals, especially humans. Examples of suchmicroorganisms include Lactobacillus acidophillus and Saccharomycescervisiae. The mineral can also include pharmaceutically acceptablebuffers, excipients, diluents, adjuvants, flavorings, and the like.

Minerals

The compositions of the present invention also include a mineral. Amineral suitable for a composition of the present invention can be anymineral that is beneficial to a host. Preferred minerals are those thataid in controlling dietary starch absorption and/or carbohydratecravings, such as, for example, vanadium and chromium.

Vanadium is an ultratrace element that is a potent nonselectiveinhibitor of protein tyrosine phosphatases. Vanadium has been shown tomimic many of the metabolic actions of insulin both in vivo and invitro. For the purposes of this invention, vanadium may be naturallyoccurring, semisynthetic or synthetic. Preferably, the vanadium is boundby a glycoprotein matrix to form a complex.

Chromium is an essential trace element that has been shown to improvethe efficiency of insulin and control dietary starch absorption andcarbohydrate cravings. For the purposes of this invention, chromium canbe naturally occurring, semisynthetic or synthetic. Preferably, thechromium is bound by a glycoprotein matrix to form a complex.

Phaseolamin

Phaseolamin is derived from Phaseolus vulgaris, or the white kidneybean. The primary function of phaseolamin is to cause temporary, safe,side-effect free malabsorption of dietary starch. Not being bound bytheory, it is believed that phaseolamin binds and neutralizesalpha-amylase. By neutralizing alpha-amylase, absorption of thecarbohydrate is inhibited. As will be discussed below, phaseolamin iseffective for inducing weight loss,

Alpha-amylase is a naturally occurring starch enzyme that is responsiblefor the breakdown of starches. For example, in humans, dietary starchesmust be broken down into smaller components, for example, glucose, inorder to be utilized by the body.

Therefore, by neutralizing the body's enzyme that breaks down starchesinto usable components, the body is unable to use those starches andultimately excretes them. In addition, starches that are not broken downinto smaller components, such as glucose, do not trigger the productionof insulin.

Amylase is a digestive tract enzyme that breaks down starch into smallunits capable of being further degraded into glucose which is used asfuel for normal metabolism and body homeostasis. Clinical use ofinhibitors of amylase has widespread appeal because a reduction ofstarch digestion will influence carbohydrate uptake in individuals inneed thereof.

Not being bound by theory, it is believed that in a composition of thepresent invention, the phaseolamin acts synergistically with both thevanadium and chromium glycoprotein complexes to enhance the effects ofthe phaseolamin, vanadium and chromium.

Insulin is a hormone naturally produced by the body that is key tocontrolling blood glucose levels. Circulating blood caries glucose thatprovides fuel for the cells. Getting glucose into the cells requiresinsulin, which is produced in the pancreas by beta cells. Normally, thepancreas produces just enough insulin to handle the body's needs. Thisis not the case with diabetics, as will be discussed below.

Carbohydrate consumption causes an abnormal rise in insulin. Excessinsulin triggers hunger and cravings, creating a vicious cycle. One wayto end the cycle is to reduce or eliminate the intake of carbohydrates.This approach has had very little or no success in inducing weight lossfor the long term. It is also extremely difficult for individuals withimpairment of glucose utilization, such as diabetes mellitus, torestrict their intake of carbohydrates.

The compositions of the present invention induce weight loss byinhibiting the absorption of carbohydrate. In addition, the compositionscontrol cravings associated with carbohydrate absorption. By inhibitingabsorption if dietary starch and controlling cravings associated withcarbohydrate absorption, the compositions of the present invention areeffective in inducing weight loss.

In addition, the compositions of the invention reduce the amount ofinsulin required by an individual suffering from diabetes mellitus.Accordingly, as will be discussed below, phaseolamin is an effective andbeneficial treatment for overweight, obese and/or morbidly obeseindividuals and for individuals suffering from diabetes mellitus.

Dietary Starch

Dietary starch is any consumable starch and is a mixture of glucans(polymers of glucose). Some examples of dietary starch sources includepasta, rice, grains, potatoes and cereals. In accordance with thepresent invention, dietary starch is composed of, for example, amyloseand/or amylopectin.

Amylose is an essentially unbranched polymer of α-glucose residues whichare joined by 1–4 glycosidic linkages. There can be about 1000 glucoseresidues per amylose molecule. Amylose forms a helical coil structureand is only slightly soluble in water due to the internal —OH groups.Amylopectin is a highly branched polymer of α-glucose residues.Amylopectin usually consists of about 20–25 glucose residues.

Other types of dietary starch include, for example, cellulose, pectin,hydrocolloids or gums and maltodextrins. Consumption of dietary starchhas been linked to weight gain, diabetes mellitus, and variousgastrointestinal conditions including, for example, irritable bowelsyndrome.

Dosage and Administration

The glycoprotein matrix compositions containing a mineral can beadministered topically or systemically. Systemic administration can beenteral or parenteral. Enteral administration is preferred. For example,the compositions can easily be administered orally. Liquid or solid(e.g., tablets, gelatin capsules) formulations can be employed. Theformulation can include pharmaceutically acceptable excipients,adjuvants, diluents, or carriers.

The compositions can be administered in chewable tablet granulations,with or without sugar, in powdered drink mixes, chewing gum and bakingproducts. In a preferred embodiment, because the compositions are stableunder baking temperatures, the compositions are effectively administeredin baking mixes such as pancakes, waffles, breads, biscuits or cookies.

In accordance with the present invention, an effective amount of aclaimed composition is any amount known to those skilled in the art.Preferably, an effective amount is administered to a host just prior to,during or shortly after consuming a starch-rich meal.

Host

In a preferred embodiment the host is a mammal. Mammals include, forexample, humans, as well as pet animals such as dogs and cats,laboratory animals such as rats and mice, and farm animals such ashorses and cows. Humans are most preferred.

A host in need of weight loss is, for example, any host where the weightof the host is not beneficial for its health. Another example of a hostin need of weight loss is, for example, a host that is unhappy with it'sappearance due to excess weight. Some examples of hosts in need ofweight loss include, but are not limited to, hosts that suffer fromdiabetes mellitus and overweight individuals.

A host is considered overweight when the body weight of the mammal isgreater than the ideal body weight according to the height and bodyframe of the host. The ideal body weight of a host is known to thoseskilled in the art. A host is considered in need of weight loss if itsbody weight is at least about 10%, preferably at least about 30%, morepreferably at least about 60%, and most preferably at least about 100%greater than their ideal body weight.

A host, for example, a human, is considered obese when its body weightis increased beyond the limitation of skeletal and physical requirementas the result of excessive accumulation of fat in the body. Obesity canbe the result of many different forces, such as, for example, overeatingor a medical condition. A medical condition that could result in obesityis, for example, a low metabolic rate.

Morbid obesity occurs when an individuals weight is two, three or fourtimes the ideal weight for that individual, and is so-called because itis associated with many seriously life-threatening disorders.

Many different approaches have been advanced for the treatment ofoverweight, obese and/or morbidly obese individuals with little successand great side-effects. The present invention provides a novelresolution which will effectively aid in inducing weight loss. Theclaimed composition comprising phaseolamin and a mineral bound by aglycoprotein matrix is effective in blocking starch absorption andcontrolling carbohydrate cravings.

The claimed composition comprising phaseolamin and a mineral, such asvanadium or chromium or both, bound by a glycoprotein matrix willprovide inhibition the absorption of starch and control carbohydratecravings.

The composition of the invention may also be used in a mammal sufferingfrom an impairment of glucose utilization, for example, diabetesmellitus. The impairment in glucose utilization may occur as a result ofa deficiency in the production of insulin by the pancreas, or byineffectiveness of the insulin produced to utilize glucose. As discussedabove, insulin is necessary to the transport of glucose from the bloodinto cells.

In diabetes mellitus, insulin is either absent, in short supply orunable to perform its job efficiently. If glucose cannot get into thecells, it accumulates in the blood creating increased blood glucose.

All clinicians recognize that dietary factors play a role in thetreatment of diabetes mellitus. In many diabetic individuals, weightloss may cure or significantly improve diabetes mellitus.

A number of meal planning systems are used in conventional diabetes caresettings. One of the most popular systems is carbohydrate counting whichinvolves maintaining a relatively constant level of carbohydrates fromday to day. By doing so, the insulin needs of the diabetic individualare more or less predictable and constant.

Individuals suffering from diabetes mellitus usually need to ingestinsulin to aid in the absorption of blood glucose into cells. Often,after consuming a carbohydrate rich meal, a diabetic's insulinrequirements may markedly increase to deal with the high blood glucoselevels.

Accordingly, by inhibiting the absorption of dietary starch, acomposition of the present invention will effectively decrease theinsulin requirements of a diabetic host.

The following examples are provided to assist in a further understandingof the invention. The particular materials and conditions employed areintended to be further illustrative of the invention and are notlimiting upon the reasonable scope thereof.

EXAMPLE 1 Preparation of Mineral+Glycoprotein Matrix (GPM) Complex

This example demonstrates the preparation of a mineral (i.e., chromiumor vanadium) plus glycoprotein matrix (GPM) complex to yield amineral+GPM complex. The method employs preparing, in a first container,an aqueous solution of USP inorganic mineral salt and adding a peptonemade of amino acids.

In a second container an active yeast solution is prepared. Activebaker's yeast, Saccharomyces cervisiae is added to water to form anaqueous solution. Maltose and gum acacia are then added.

The first container containing the mineral is then inoculated veryslowly into the active yeast solution to form a live fermented solution.The mixture is allowed to ferment for four to six hours. To promoteyeast growth, plant proteins and carbohydrates are added. Proteolyticenzyme, such as papain, is then added.

Lactobacillus acidophillus is added to the live fermented solution andallowed to ferment for about 2 hours. Active fermentation is thenstopped by heating the solution to 160–170° F. for three hours.

The fermented mineral solution is then homogenized in a shearing pump(Charles Ross & Sons Corp.) for approximately 1–2 hours and spray dried(NIRO, Nicholas Engineers Research Corp.) for approximately 4 hours. Theresulting product is a powder containing the mineral GPM complex.

EXAMPLE 2 Preparation of Phaseolamin

Whole dried non-genetically modified organism (GMO) Phaseolus vulgarisbeans were inspected for cleanliness. Upon quality control approval ofthe beans, the dried beans were milled and placed in a solvent,preferably water, or an alcohol-water mixture.

Phaseolamin was extracted from the bean fraction multiple times understrict standard operating procedures as are known to those in the art,such as, for example, affinity chromatography. The extracted phaseolaminwas then spray dried and tested for bacterial contamination, mesh (i.e.,particle size), moisture content, potency, and organoleptics (i.e.,physical characteristics, such as, color, taste, odor, powder, andliquid).

EXAMPLE 3 Preparation of Phaseolamin with Mineral+GPM Complex

Phaseolamin was added to a mineral+GPM complex (obtained from Example 1)and mixed together. The resulting mixture yielded a compositioncomprising phaseolamin and a mineral+GPM complex. This method may beused to prepare, for example, 1) phaseolamin with chromium+GPM complex;2) phaseolamin with vanadium+GPM complex; and 3) phaseolamin withchromium+GPM complex and vanadium+GPM complex. The methods for preparingthe above listed compositions are briefly described below.

Briefly, to prepare phaseolamin with a chromiun+GPM complex, 4500 mgs ofphaseolamin was added to 3 mgs of chromium+GPM complex and mixedtogether. The resulting mixture yielded 6 μg of elemental chromium per4.5 g of phaseolamin.

To prepare phaseolamin with a vanadium+GPM complex, phaseolamin at 4500mgs was added to 3 mgs of vanadium+GPM complex and mixed together. Theresulting mixture yielded 6 μg of elemental vanadium per 4.5 g ofphaseolamin.

To prepare phaseolamin with chromium+GPM complex and vanadium+GPMcomplex, 4500 mgs of phaseolamin at was added to 1.5 mgs of chromium+GPMcomplex and 1.5 mgs of vanadium+GPM complex and mixed together. Theresulting mixture yielded 3 μg of elemental chromium and 3 μg ofelemental vanadium per 4.5 g of phaseolamin.

EXAMPLE 4 Efficacy of Phaseolamin

To study the efficacy of phaseolamin, five males and five females (ages21 to 57) participated in a double-blind placebo-controlled crossoverstudy. All subjects were instructed to go about their usual dailyroutines throughout the study. After an overnight fast, the participantswere sampled for blood and then given in a random manner either:

-   -   Group 1) (placebo) a starch meal consisting of 4 slices of white        bread (60 grams of carbohydrate) with 42 grams of soybean oil        margarine and 4 grams of Sweet N' Low spread on the bread; or    -   Group 2) a starch meal consisting of 4 slices of white bread (60        grams of carbohydrate) with 42 grams of soybean oil margarine        and 4 grams of Sweet N' Low spread on the bread; plus 1.5 grams        of Phaseolamin 2250™ (Pharmachem Laboratories).

Plasma glucose was measured by a commercial enzyme kit (Sigma ChemicalCompany) from blood drawn at baseline, and every 30 minutes for 4 hours.After one week the regimen was repeated where the starch meal containingPhaseolamin 2250™ was administered to the subjects group 1 and thesubjects in group2 were administered the starch meal without Phaseolamin2250™.

The subjects were normoglycemic as measured by fasting glucoseconcentration which averaged 98 mg/dl for the placebo and 104 for thePhaseolamin 2250™ starch meal. From 60 to 120 minutes after consumptionof the starch meal, the change in plasma glucose of the Phaseolamin2250™ group from the baseline was ½ to ⅓ of the level of the placebogroup (FIG. 1). Phaseolamin 2250™ consumption caused the plasma glucoseto return to baseline values 20 minutes earlier than the placebo withoutPhaseolamin 2500™.

The average area under the plasma glucose time curve from 0 to 150minutes, which is a measure of absorption and metabolism, was 57% lowerwith Phaseolamin 2250™. Plotting the average change in glucoseconcentration from 30 minutes to 210 minutes, the area under the curvewas positive for the placebo but negative for Phaseolamin 2250™.

This indicates that very little of the glucose from the starch in thebread was absorbed when co-ingested with Phaseolamin 2250™ and that theglucose was cleared very rapidly. No side effects were observed insubjects treated with Phaseolamin 2250™.

1. A method for inhibiting absorption of dietary starch in a host,wherein said method comprises administering to said host, an effectiveamount of a composition comprising effective amounts of phaseolamin andvanadium, wherein said vanadium is bound by a glycoprotein matrix,wherein the glycoprotein matrix is a molecular network comprising aplurality of glycoproteins bound together, and wherein the glycoproteinsare produced by Lactobacillus acidophilus and Saccharomyces cervisiae.2. A method according to claim 1, wherein said composition furthercomprises stabilizers and/or additives.
 3. A method according to claim1, wherein said dietary starch is amylose.
 4. A method according toclaim 1, wherein said host is a human.
 5. A method according to claim 4,wherein said human is obese.
 6. A method according to claim 4, whereinsaid human is morbidly obese.
 7. A method according to claim 4, whereinsaid human suffers from an impairment of glucose utilization.
 8. Amethod according to claim 1, wherein said composition is administered ina baked good.
 9. A method according to claim 8, wherein said baked goodis selected from the group consisting of pancake, waffle, bread, biscuitand cookie.
 10. A method for inducing weight loss in a host in needthereof, said method comprising administering an effective amount of acomposition comprising effective amounts of phaseolamin and vanadium,wherein said vanadium is bound by a glycoprotein matrix, wherein theglycoprotein matrix is a molecular network comprising a plurality ofglycoproteins bound together, and wherein the glycoproteins are producedby Lactobacillus acidophilus and Saccharomyces cervisiae.
 11. A methodaccording to claim 10, wherein said composition further comprisesstabilizers and/or additives.
 12. A method according to claim 10,wherein said host is a human.
 13. A method according to claim 12,wherein said human is obese.
 14. A method according to claim 12, whereinsaid human is morbidly obese.
 15. A method according to claim 12,wherein said human suffers from an impairment of glucose utilization.16. A method according to claim 11, wherein said composition isadministered in a baked good.
 17. A method according to claim 16,wherein said baked good is selected from the group consisting ofpancake, waffle, bread, biscuit and cookie.
 18. A method for controllingcarbohydrate cravings in a host in need thereof, said method comprisingadministering to said host an effective amount of a compositioncomprising effective amounts of phaseolamin and vanadium, wherein saidvanadium is bound by a glycoprotein matrix, wherein the glycoproteinmatrix is a molecular network comprising a plurality of glycoproteinsbound together, and wherein the glycoproteins are produced byLactobacillus acidophilus and Saccharomyces cervisiae.
 19. A methodaccording to claim 18, wherein said composition further comprisesstabilizers and/or additives.
 20. A method according to claim 18,wherein said host is a human.
 21. A method according to claim 20,wherein said human is obese.
 22. A method according to claim 20, whereinsaid human is morbidly obese.
 23. A method according to claim 20,wherein said human suffers from an impairment of glucose utilization.24. A method according to claim 18, wherein said composition isadministered in a baked good.
 25. A method according to claim 24,wherein said baked good is selected from the group consisting ofpancake, waffle, bread, biscuit and cookie.